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Recent Developments in Clinical Pharmacology: Dose Optimization, PBPK Modeling, TQT Waiver, Pediatric Dose Projection, and AI/ML Case Studies
Clinical pharmacology continues to advance through innovative approaches that enhance drug development efficiency and decision-making. This session will highlight the expanding role of quantitative methods across the development spectrum—from first-in-human to post-marketing. Topics will include PK/PD and PBPK modeling for dose and schedule optimization, use of simulations in lieu of clinical DDI studies, approaches to TQT study waivers, and pediatric dose projections. The session will also explore emerging applications of artificial intelligence and machine learning in pharmacometrics and illustrate model-informed strategies supporting NDA/BLA submissions. Collectively, these discussions will demonstrate how model-informed drug development (MIDD) is reshaping clinical pharmacology and enabling more efficient, science-driven regulatory and clinical decision-making.
Session Topics:
- Overview of the Clinical Pharmacology Package for NDA/BLA Submissions
- PK/PD Modeling in Dose and Schedule Optimization During Early Clinical Development
- PBPK Modeling in Lieu of Clinical DDI Studies: Current Status
- Path to TQT Study Waiver: Data Requirements in Research and Development
- Pediatric Dose Projection: Role of Modeling and Simulation
- Developments in Artificial Intelligence and Machine Learning in Pharmacometrics
- Model-Informed Clinical Pharmacology Development: Case Studies from First-in-Human to Post-Marketing
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